Nitrogen Gas - FDA Label NDC 52438-016

The following Structured Product Label (SPL) was submitted to the FDA by Messer Llc for the product Nitrogen (NDC 52438-016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warnings section, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings Section

Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”

Package Label.Principal Display Panel

Linde

Certicate of Analysis - Nitrogen NF

Product: Nitrogen NF

Date
Facility Name
Facility Address
Lot#		Batch #

Final Analysis Results

Analyzer #	Test/Units	NF Specs	Analysis Results
N/A	Odor	None
	ppm O2	< 10,000 (Linde Spec <5.0)	ppm
	ppm CO	< 10.0	ppm
	ppm THC	N/A	ppm
	ppm H2O	N/A	ppm
	ppm CO2	N/A	ppm
	ppm H2	N/A	ppm
Assay Results	Nitrogen min %	> 99.0% (Linde Spec >99.999%)	%

NT= not tested

PPM O2 Method Used: __________________________

Manufacturer/

Model #: __________________________

PPM O2 Method Used:

__________________________

Manufacturer/Model #:

__________________________

This analyzer has been validated by Linde as acceptable alternatives to the official NF for Nitrogen Assay. Validation study documentation is maintained by Linde at the corporate offices.

Analyst	Date

Quality Reviewer	Date

Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”

2.4 October 2017

ASU-22-06-GAM-Medical Gas Procedures

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Retention Period – 3 Years

Nitrogen Gas
FDA Label NDC 52438-016

Structured Product Label

Label Section Quick Index

Warnings Section

Package Label.Principal Display Panel